Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR
Health Products Regulatory Authority (HPRA), Ireland
Dr Tom Melvin is clinical manager and part of the high level management team of medical devices at the HPRA. Prior to this, Tom worked for the HPRA as a medical officer in medical devices. Tom holds a degree in medicine, from the Royal College of Surgeons in Ireland, in addition to a degree and masters in law from University College Dublin. Tom is Co-Chair of the Clinical Investigation and Evaluation Working Group, and in addition to chairing, Tom has led a number of taskforces at CIE, and a number of other Working Groups and European Taskforces.
Dr Melvin will present on clinical investigations and the Medical Device Regulation, in addition to providing an update on recent activity of the Clinical Investigation and Evaluation Working Group and the plans for future work.